The FDA's Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee gave the agency a lot to ponder as it considers whether to approve Mallinckrodt plc's new immediate-release (IR) formulation of oxycodone and determines if it warrants abuse-deterrent labeling. Read More
DUBLIN – There are 98 antibody-drug conjugate (ADC) monotherapy development programs currently in the clinic, in addition to the four products already on the market, Steve Coats, vice president of R&D at the Medimmune arm of London-based Astrazeneca plc, told the audience at a workshop session on ADC warheads at the 30th annual EORTC-NCI-AACR meeting Wednesday. "They're probably not the magic bullets we had anticipated," he admitted. Nevertheless, interest in those agents remains high because of their ability to elicit responses in highly refractory cancer patients. Read More
SAN FRANCISCO – Acquist Therapeutics Inc., a Westfield, N.J.-based company targeting enzymes that regulate both production and excretion of uric acid (UA), reported that in human liver cells treated with a nonalcoholic steatohepatitis (NASH) promoter, its lead candidate, ACQT-1127, blocked a 70-fold increase in UA by more than 98 percent and reduced by more than half a marked increase in triglycerides. The candidate also brought dysregulated levels of seven NASH-related activators back within normal range, it said. Read More
Distinguishing indolent cancer, which is unlikely to spread, from an aggressive tumor that will metastasize to different parts of the body remains a challenge in practice. That makes it easy to overtreat indolent cancer, which is thought to be common particularly among prostate and breast cancers. Read More
Rxi Pharmaceuticals Corp., of Marlborough, Mass., plans to change its name to Phio Pharmaceuticals Corp. and change its ticker symbol from RXII to PHIO, which will become effective in the coming week. Read More
Effrx Pharmaceuticals SA, of Freienbach, Switzerland, appointed Lorraine Zakin director, medical affairs, Peter Lichtlen chief medical advisor, Christiane Sievert director, regulatory affairs and Victor Papavasileiou vice president, business development. Read More
Prometic Life Sciences Inc., of Laval, Quebec, said it closed its transaction with Structured Alpha LP, extending maturity dates of its $80 million line of credit and original issue discount notes to September 2024. Read More
